Essure Permanent Birth Control
- Benefits of Essure
- FDA’s Review of Reported Problems
- Pregnancy Following Essure Placement
- Patients with problems involving Essure
- Additional Information
Essure is a permanent birth control method for women that creates a barrier against pregnancy. It involves placing soft, flexible inserts into the fallopian tubes, which carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Essure can be an effective means of female sterilization when health care providers and patients follow the appropriate instructions for use.
- Essure is the only sterilization choice that does not require a skin incision for women who want permanent birth control.
- The Essure procedure is 99.83 percent effective when used according to the approved instructions for use based on five-year clinical study data.
- Patients do not require general anesthesia when Essure is placed in the fallopian tubes.
- Essure inserts do not contain or release hormones.
- Recovery is quicker than other types of sterilization. Most women can go home 45 minutes after the procedure, and return to normal activity within one to two days.
Some women have reported to the FDA that they have experienced certain health problems after using Essure, such as pain. These problems are known through clinical studies, and they are addressed in the Essure product information (labeling). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature. They include extreme fatigue, depression and weight gain.
The FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. The FDA conducted a thorough review of the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. This includes experiences of patients who have had positive outcomes with Essure as well as those who have experienced problems. Specifically, the FDA has taken the following actions:
- We reviewed Essure patient reports of problems (including web-based testimonials) and reports of problems submitted to the FDA from other sources, including doctors, patients, and the manufacturer of Essure, Conceptus Inc. (Bayer acquired Conceptus on June 5, 2013.)
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure's approval date, through Oct. 25, 2013, the FDA received 943 reports of adverse events related to Essure. The most frequently reported adverse events were pain (606), hemorrhage (140), headache (130), menstrual irregularities (95), fatigue (88), and weight fluctuations (77). The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37).
Adverse event and product problem reports submitted to the FDA are just one source we use to monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has notable limitations. For example, complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence. For these reasons, the FDA also evaluates other information to make decisions about a device's safety and effectiveness once a device is on the market, including post-approval studies and review of the clinical literature.
We reviewed the results from a five-year study conducted by Conceptus and required by the FDA as part of the product’s 2002 approval. This post-approval study evaluated:
- how well Essure prevented pregnancy;
- the safety of the procedure used to place Essure; and,
- the safety of Essure once implanted, including patient comfort.
Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known.
- We evaluated the available clinical literature to determine what long-term complications may be associated with Essure more than five years after placement, because the post-approval study only evaluated safety and effectiveness up to five years. To date, we have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.
To date, none of the above information the FDA reviewed has established a causal connection between Essure and certain reported problems, such as extreme fatigue, depression, and weight gain.
While scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100 percent effective. The Essure procedure is 99.83 percent effective when used according to the approved instructions for use based on five-year clinical study data.
At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature show no increased risk of neonatal or pregnancy complications, as long as the pregnancy is in the uterus.
The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks.
- seek a thorough evaluation from their health care provider and be sure to receive the proper follow-up.
- submit a voluntary report about any problems experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program. The FDA reviews the MedWatch reports and takes any necessary action to protect public health. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.